CellSeed Inc. · 2020. 6. 29. · • Commercialization of Cell Sheet Therapies Regenerative Medicine ... Dec. 2019: Held a press conference in cooperation with MetaTech at Healthcare

JASDAQ Growth Stock Code: 7776

CellSeed Inc.Fiscal 2019

Earnings Results Presentation

Copyright © 2020 CellSeed Inc. All Rights Reserved.

Company Profile

Financial Summary FY12/2019

Mid-term Business Plan Fiscal Year 2020 to Fiscal Year 2022

1

Contents

Copyright © 2020 CellSeed Inc. All Rights Reserved. 2

CellSeed Inc. Corporate Information

UpCell®

CPC

• Contract Manufacturing Services・ Consulting

Established May, 2001Core competence Cell Sheet Engineering based on Temperature

Responsive PolymersListed JASDAQ（7776) in 2010Business

Regenerative Medical Products Business

• Commercialization of Cell Sheet Therapies

Regenerative Medicine Supporting Business

• Intelligent Culture Ware as Research Tools


Our Business Model

UniversityBase of Innovation

Hospitals

Patients

Seeds

Collaborative Research

Products

Fee

Partner Companies

Business Alliance

MissionWe take the initiative of contributing to global health care in the valuable and innovative field of regenerative medicine.

Medical Treatment

Medical Expenses


Development of Treatment Using Cell Sheet Engineering

Cell Sheet

Cornea Periodonrium Middle ear

Pancreas Liver Heart Lung

Esophagus Cartilage


0

20

40

60

80

100

12019

9019

9119

9219

9319

9419

9519

9619

9719

9819

9920

0020

0120

0220

0320

0420

0520

0620

0720

0820

0920

1020

1120

1220

1320

1420

1520

1620

17

総出願件数

⽂献数

Establishment of CellSeed Inc

Overseas sales for Upcell🄬 launched

CSTEC

Expansion of Cell Sheet Engineering

Papers

Patents


Company Profile



6

Contents


Net Sales

Operating Profit

Ordinary Profit

Profit attributable to owners of

parent

Profit per share—basic

Forecast（Ａ） 300 -1,100 -1,100 -1,100 -93.6

Actual（B） 275 -780 -786 -782 -66.6

Change (Millions of Yen)（B－A） -24 319 313 317 －

Change（％） -8.1% －－－－

FY2018 1,026 140 140 129 ¥11.35

Financial Summary for the Fiscal Year Ending December 2019(Unit: Million yen; Presented with fractions less than one million yen rounded off)

Regenerative medicine supporting business: Especially, the overseas sales of equipment grew considerably year on year, hitting a record high. The business of consigned manufacturing of cell sheets was launched in November 2018, using the cell processing facility, and posted sales for the first time in 2019.

Cell sheet regenerative medicine business: The milestone sales from the exclusive business alliance contract in Taiwan stood at 158 million yen.

Profit on sales exceeded the estimate, mainly because the expenses for outsourcing development tasks, maintaining the cell processing facility, etc. fell below the initial estimate.


A medical treatment developed by Tokyo Women’s Medical

University as a regenerative treatment for esophageal cancer (to

heal esophageal wound and prevent stricture)

Cell sheet is on a temperature-responsive cell culture ware and

then transplanted into the ulcerated area in the esophagus after

endoscopic surgery for esophageal cancer

8

Epithelial Cell Sheet for Esophageal Regeneration (CLS2702C/D)


Clinical Research and Clinical Trials of Esophageal Cell Sheet

Clinical Trials sponsored by CellSeed

Basic Development

Agreement

Tokyo Women’s Medical University

Clinical Research at Universities2008－2014＜Japan＞

Tokyo Womenʼs Medical Univ. 10case

Tokyo Womenʼs Medical Univ. and Nagasaki Univ. 10case

＜Europe＞

Karolinska University Hospital 10case

Taiwan(MetaTech)JapanEurope(Sweden) Submitted a notification of clinical trial plan

on 2016 “SAKIGAKE Designation” in Feb. 2017 Completed the clinical trial in Japan Conduct consultation with PMDA on

additional trial

MetaTech has submitted IND in Taiwan.


Cell Sheet Regenerative Medicine Business in the Fiscal Year Ended December 2019

10

• It became necessary to apply the sheet to patients who may suffer from

adverse effects of steroid administration in additional clinical trials.

• We are having a discussion with PMDA about target patients and the number

of cases.

Epithelial Cell Sheet for Esophageal Regeneration

Summer in 2016 Clinical trial commenced.

1Q in 2019 Clinical trial finished.

From 2019 Having a discussion with PMDA about additional clinical trials

Clinical trial for obtaining approval

Guidelines for esophageal cancer diagnosis in 2017

Steroid became popular as a major treatment for preventing stenosis.


Chondrocyte Sheet

11

Go Omori, Yoshio Koga and others From epidemiological survey for osteoarthritis of the knee

Disease characteristics

• Causes︓ageing・obesity traumatic・• No treatment to regenerate lost cartilage is available

In Japan, estimated number of potential patients 25,300,000 persons of

which, 8,000,000 shows symptoms (22nd Century Medical and Research Center)


Overview of Chondrocyte Sheet Project

Basic Development

Agreement

＜ Autologous Cells ＞• 2019/1

approved by the MHLW in the 71st Conference on Advanced Medicine

＜ Allogeneic Cells ＞• 2019/12

completed transplants of 10 cases

Taiwan

• Licensing out Autologous cell sheet to MetaTech in Taiwan

• Commercialization of Allogenic Chondrocyte Sheet Product

Developed by Prof. Masato Sato,Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine


Autologous chondrocyte sheets

Indications︓Knee Osteoarthritis

chondrocyte sheets

Collect Autologous Cartilage Cells

Manufacture Cell Sheet

Transplant to Patient


Allogeneic chondrocyte sheets

Clinical Research at Tokai University

• Completed in December 2019 transplants of 10 cases

• selected for the 2018 Project Focused on Developing Key Evaluation Technology:Acceleration of Developing Regenrative Medicine Technology Seeds (for 3 years, from October 2018 to March 2021.)

Manufacturing・QC・Shipping

Culture

Polydactyly donors

Cell Suspension In liq.Nitrogen

ThawingCulture

ManufactureCell Sheet

Packaging

Quality/Safety

Evaluation test

Lotrelease test

Preparation of Cell StockMasterCell Bank

Working CellBank

Transport-ation

Clinical use

In liq.Nitrogen

Collection of tissue

Transport-ation


Cell Sheet Regenerative Medicine Business in the Fiscal Year Ended December 2019

Regenerated Cartilage Sheet

15

Autologous Chondrocyte Sheet Jan. 2019

“The cartilage regeneration treatment with autologous cell sheets” proposed by Tokai University

Hospital, with which we conduct joint research, was approved at the 71st advanced medical care

meeting.

Nov. 2019

Together with Professor Sato of Tokai University, we applied for a patent regarding “manufacturing

and utilization methods of cell culture sheets” in the U.S. and were granted the patent, to protect

our intellectual property in Japan, the U.S., and Europe.

Allogeneic cells Dec. 2019

In Tokai University, allogeneic cartilage cell sheets were transplanted into 10 patients in clinical

research.

Since the system for supplying human tissue for commercial use had not been established, it took

time to obtain human tissue and the commencement of clinical trials was delayed.


CellSeed Temperature Sensitive Cell Cultureware Lineup

16

UpCell®Cell Sheet Recovery

（Temperature Sensitive）

RepCell TM

Cell Recovery（Temperature Sensitive）

HydroCell ™Ultra-Low Adhesion Cell

Cultureware

3 x 3 mm Grid Wall


Acquisition of ISO 9001: 2015 Certification

We offer consistent quality and services in the design of and manufacturing control of

cell cultureware. To further improve client satisfaction, we have constructed a quality

management system and acquired certification under the international standard,

ISO9001: 2015. Aiming to boost client satisfaction, we will comply with this standard

and with all relevant laws and regulations as we carry out continuous improvement of

quality management.

Date of registration : January 6, 2020 Period of validity : January 6, 2023 Scope of registration : Design and manufacturing

control of cell culturewareSales of special cell monitoring devicesand measuring instruments


Regenerative Medicine Supporting Business1. Regenerative Cell Sheet Product Manufacture Method Development, Consigned Manufacture

2. Facility Management, Application Submission Support

3. Cell Culturing Technician Training

Consigned manufacture Manufacture method

development Quality testing＜Characteristics＞• Cell sheet manufacturing using

UpCell®• Certified facility for specific cell

processing (FA3160008)• Japanese Society for Regenerative

Medicine Certified Clinical Culturing Specialist, including large number of staff with bountiful experience and knowledge of culturing technologies

Support for certification application, notification for specific cell processing

Document creation for procedural manual, standard handbook, others consulting

Cell processing center facilities, support management structure, maintenance provision

Application document creation, others

Cell sheet culturing training

Cell sheet peeling training, others


Regenerative Medicine Supporting Business in the Fiscal Year Ended December 2019

19

Sales of Equipment We collected information on sales of equipment from major

distributors and conducted marketing activities in

cooperation with distributors for sales promotion.

We participated in many exhibitions, to promote sales

actively.

Especially, overseas sales increased considerably.

Sales hit a record high.

Contract Development and Manunfactiring Service

Received the first order for the cell sheet for doctor-led

clinical trials of periodontal ligament cell sheets from

Tokyo Women's Medical University.

Conducted cell sheet culture training for academia.

2016 2017 2018 2019

Variation in sales of equipment


Close collaboration with academia

20

1st Cell Sheet Engineering Innovation Forum July 19, 2019200 people attended

Keynote speech ︓Prof. Teruo Okano

Presentations of clinical applications

• Dr. Takanori Iwata : periodontal ligament

• Dr. Goshi Shiota : liver diseases

• Dr. Shuichi Sekine : construction of 3D organ

• Dr. Masato Sato : osteoarthritis

Poster awards for young researchers

• Best Performance Award

Dr. Tetsuya Imamura（Shinshu Univ. )

• outstanding performance award

Dr. Takumi Takahashi (Tokai Univ. )

Dr. Tetsutaro Kikuchi (Tokyo Women’s Medical Univ. )


Dr.Tetsuya IMAMURAAssistant Professor

Shinshu University

Department of Urology, School of Medicine

Research Field

Regenerated Medicine, Lowr Urinary Tract Medicine

Production of Application Notes

Dr. Tetsuya Imamura of Shinshu University

21

At the first cell sheet engineering innovation forum, he

received the most excellent poster award.

He engages in regenerative medicine research with

the tissue engineering method using mesenchymal

stem cells in the department of urology.


2nd Cell Sheet Engineering Innovation Forum

Date : October 15, 2020

Venue : Miraikan

Capacity : 200 people

Theme

: “Cell Sheet” or research using

”temperature-responsive cell

cultureware”

Presentations of

clinical

applications

• Dr. Tatsuya Shimizu

(Tokyo Women’s Medical Univ. )

• Dr. Yuji Miyahara

(Tokyo Medical and Dental Univ.)

• Dr. Ryoichi Sakiyama

(Osaka Institute of Technology)


Other activities FY12/2019

23

Nov. 2019: Our company and MetaTech in Taiwan took the initiative in

joint investment.

Dec. 2019: Held a press conference in cooperation with MetaTech at

Healthcare EXPO TAIWAN.

Jan. 2020: Established a joint venture.


Name Up Cell Biomedical Co.

Address 14F.-2, No. 75, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan (R.O.C.)

Representative President Andrew H.-J. Wang

Business operations

establish utilize the seeds technology provided by Japanese or Taiwanese universities and research institutions in order to develop regenerative medicine products and therapies using cell sheet engineering

Capital NT$130,000,000 (at establishment; approx. 500,000,000 yen)

Establishing Up Cell Biomedical Co.


Overview of Up Cell Biomedical Inc.

Seedtechnologies

Jointresearch

Products

Hospitals

Patients

Universities/hospitals

(Taiwan and Japan)

Compensation

Treatment

Medicalcosts

Director Du,E-DA Hospital

Shareholders

Board Members

President / Andrew H.-J. Wang

Vice President / Ho Hung-Neng

Director / Setsuko Hashimoto

Advisor

Yang, Zhi-Hui

Scientific Advisory Board

Chen Yaochang

Huang Yen-Hua

Masayo Takahashi


Promoting Global Business Alliances

Scheduled Participation in Exhibitionsin 2020 (Outside Japan)

May / China BIO (Suzhou)

December / BioUS (San Diego)

June / Bio Asia Taiwan (Taipei)

July / BIO Partnering APAC 2020 (Shanghai)

September / BIOEU Fall (Germany)

October / Healthcare EXPO TAIWAN (Taipei)


Company Profile



Contents



Epithelial Cell Sheetsfor EsophagealRegeneration

Discussions are moving forward with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on an additional clinical trial. Seek for early manufacturing and salesapproval.

Chondrocyte Sheet(Autologous Cells)

Proceed the contract manufacturing of cell sheets for advanced medical technology from Tokai University.

Chondrocyte Sheet(Allogeneic Cells)

Acceleration of building of cell stock and automation of cell sheet manufacturing for early start ofcrinical trials.

Third Line ofProducts

Discussions for further study of periodontal ligament cell sheetswith Tokyo Medical and Dental University.

Business Alliances

We are actively pursuing business alliances to promote the global development of made-in-Japan cell sheet engineering.

An EarningsOpportunity in Taiwan

With a focus on expandinginvestment in regenerativemedicine in Taiwan, cooperative efforts are being strengthened with MetaTech (AP) Inc. and the joint venture.

CulturewareBusiness

To develop new products andexpand production capacity to meet increasing demand forfurther earning expansion.

ContractManufacturing

To accelerate contract manufacturing and consulting business for further earnings gain.


(Unit: Million yen; Presented with fractions less than one million yen rounded off)

Net Sales Operating Profit Ordinary ProfitProfit

attributable to owners of parent

FY2020（Estimate） 310 -1,020 -1,020 -1,020

FY2021（Target） 360 -1,030 -1,030 -1,030

FY2022（Target） 1,400 10 10 8

Mid-term Business Plan (2020 – 2022) Financial Targets

*sales composition (Millions of yen)

Regenerative Medical Products Business

FY2020 : 230 FY2021 : 320 FY2022 : 390

Regenerative Medicine Supporting Business

FY2020 : 80 FY2021 : 40 FY2022 : 1,010


This presentation is made by CellSeed Inc. solely for the disclosure of the

financial statements, and not published for the purpose of soliciting sales or

purchases of securities in Japan and any other regions.

Documents

CellSeed Inc. · 2020. 6. 29. · • Commercialization of Cell Sheet Therapies Regenerative Medicine ... Dec. 2019: Held a press conference in cooperation with MetaTech at Healthcare